Overview

The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) of 20 to 35 kg/m2.
• Visible excess of adipose tissue at the treatment sites (ARM 1 - thigh area; ARM 2 - saddlebags area).
• Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
• No procedure for fat reduction (including cellulite treatment) in the last six months.
• Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation.
• Age between 21 and 70 years.

Exclusion Criteria:

• Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
• Cardiovascular diseases
• Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
• Femoral or inguinal hernia
• Disturbance of temperature or pain perception
• Pulmonary insufficiency
• Metal implants
• Drug pumps
• Malignant tumor
• Hemorrhagic conditions
• Septic conditions and empyema
• Acute inflammations
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Pregnancy
• Breastfeeding
• Injured or otherwise impaired muscles
• Scars, open lesions, and wounds at the treatment area
• Basedow's disease
• Previous liposuction in the treatment area in the last six months
• Unstable weight within the last 6 months (change in weight 3%)
• Previous body contouring or cellulite treatments in the thighs area in the last six months
• Any other disease or condition at the investigator's discretion